- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03451890
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730 in Healthy Participants
1. marts 2019 opdateret af: Eisai Inc.
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730 in Healthy Subjects
This study will be conducted to evaluate the safety, tolerability, and pharmacokinetics of single ascending oral doses of E2730 in healthy adult participants.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
32
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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California
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Long Beach, California, Forenede Stater, 90806
- Collaborative Neuroscience Network
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 55 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Non-smoking, male or female, age ≥18 years and ≤55 years old at the time of informed consent (Note: To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing.)
- Body mass index (BMI) ≥18 and <32 kilograms per meters squared (kg/m^2) at Screening
Exclusion Criteria:
- Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [β-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 International Units per liter (IU/L) or equivalent units of β-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
- Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period or for 5 times the half-life of the study drug plus 90 days after study drug discontinuation). No sperm donation is allowed during the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation.
- Participants with history of seizures, including those experienced in childhood
- Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of E2730, e.g., hepatectomy, nephrectomy, and digestive organ resection
- A prolonged QT/QTc interval (QTcF >450 milliseconds) demonstrated by a repeated ECG at Screening or Baseline (based on average of triplicate ECGs). A history of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolonged the QT/QTc interval
- Persistent systolic blood pressure (BP) >139 or <90 millimeters of mercury (mmHg) or diastolic BP >89 or <50 mmHg at Screening or Baseline
- Left bundle branch block
- History of myocardial infarction or active ischemic heart disease
- History of clinically significant arrhythmia or uncontrolled arrhythmia
- Known history of clinically significant drug allergy at Screening
- Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening
- Known to be human immunodeficiency virus (HIV) positive at Screening
- Active viral hepatitis (A, B, or C) as demonstrated by positive serology at Screening
- History of drug or alcohol dependency or abuse, or those who have a positive drug test at Screening or Baseline
- Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5 half-lives, whichever is longer, preceding informed consent
- Participants who undergo blood transfusion within 12 weeks, or who donate 400 milliliters (mL) or more of whole blood within 12 weeks or 200 mL or more of whole blood within 4 weeks, or who make a component donation within 2 weeks prior to dosing
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Cohort 1: E2730 40 mg
Participants will receive a single oral dose of E2730 40 milligrams (mg) under fasted conditions.
|
oral capsule
|
Placebo komparator: Cohort 1: Matching placebo
Participants will receive a single oral dose of matching placebo under fasted conditions.
|
oral kapsel
|
Eksperimentel: Cohort 2: E2730 80 mg
Participants will receive a single oral dose of E2730 80 mg under fasted conditions.
|
oral capsule
|
Placebo komparator: Cohort 2: Matching placebo
Participants will receive a single oral dose of matching placebo under fasted conditions.
|
oral kapsel
|
Eksperimentel: Cohort 3: E2730 120 mg
Participants will receive a single oral dose of E2730 120 mg under fasted conditions.
|
oral capsule
|
Placebo komparator: Cohort 3: Matching placebo
Participants will receive a single oral dose of matching placebo under fasted conditions.
|
oral kapsel
|
Eksperimentel: Cohort 4: E2730 160 mg
Participants will receive a single oral dose of E2730 160 mg under fasted conditions.
|
oral capsule
|
Placebo komparator: Cohort 4: Matching placebo
Participants will receive a single oral dose of matching placebo under fasted conditions.
|
oral kapsel
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mean maximum observed concentration (Cmax) for E2730 and the N-acetyl metabolite (M1) in plasma
Tidsramme: predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours (hr) postdose (PD) on Day 1; thereafter on Day 2 (24 hr PD), Day 3 (48 hr PD), Day 4 (72 hr PD), Day 5 (96 hr PD), Day 6 (120 hr PD), Day 7 (144 hr PD), and Day 10 (216 hr PD), and Day 13 (288 hr PD)
|
predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours (hr) postdose (PD) on Day 1; thereafter on Day 2 (24 hr PD), Day 3 (48 hr PD), Day 4 (72 hr PD), Day 5 (96 hr PD), Day 6 (120 hr PD), Day 7 (144 hr PD), and Day 10 (216 hr PD), and Day 13 (288 hr PD)
|
|
Time at which the highest drug concentration (tmax) occurs for E2730 and the N-acetyl metabolite (M1) in plasma
Tidsramme: predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours (hr) postdose (PD) on Day 1; thereafter on Day 2 (24 hr PD), Day 3 (48 hr PD), Day 4 (72 hr PD), Day 5 (96 hr PD), Day 6 (120 hr PD), Day 7 (144 hr PD), and Day 10 (216 hr PD), and Day 13 (288 hr PD)
|
predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours (hr) postdose (PD) on Day 1; thereafter on Day 2 (24 hr PD), Day 3 (48 hr PD), Day 4 (72 hr PD), Day 5 (96 hr PD), Day 6 (120 hr PD), Day 7 (144 hr PD), and Day 10 (216 hr PD), and Day 13 (288 hr PD)
|
|
Mean area under the concentration-time curve from zero time to 24 hours after dosing (AUC[0-24h]) for E2730 and the N-acetyl metabolite (M1) in plasma
Tidsramme: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours postdose on Day 1; Day 2 (24 hours postdose)
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predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours postdose on Day 1; Day 2 (24 hours postdose)
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Mean area under the concentration-time curve from zero time to time of last quantifiable concentration (AUC[0-t]) for E2730 and the N-acetyl metabolite (M1) in plasma
Tidsramme: predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours (hr) postdose (PD) on Day 1; thereafter on Day 2 (24 hr PD), Day 3 (48 hr PD), Day 4 (72 hr PD), Day 5 (96 hr PD), Day 6 (120 hr PD), Day 7 (144 hr PD), and Day 10 (216 hr PD), and Day 13 (288 hr PD)
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predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours (hr) postdose (PD) on Day 1; thereafter on Day 2 (24 hr PD), Day 3 (48 hr PD), Day 4 (72 hr PD), Day 5 (96 hr PD), Day 6 (120 hr PD), Day 7 (144 hr PD), and Day 10 (216 hr PD), and Day 13 (288 hr PD)
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Mean area under the concentration-time curve from zero time to 72 hours after dosing (AUC[0-72h]) for E2730 and the N-acetyl metabolite (M1) in plasma
Tidsramme: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours postdose on Day 1; thereafter on Day 2 (24 hours postdose), Day 3 (48 hours postdose), Day 4 (72 hours postdose)
|
predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours postdose on Day 1; thereafter on Day 2 (24 hours postdose), Day 3 (48 hours postdose), Day 4 (72 hours postdose)
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Mean area under the concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf]) for E2730 and the N-acetyl metabolite (M1) in plasma
Tidsramme: predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours (hr) postdose (PD) on Day 1; thereafter on Day 2 (24 hr PD), Day 3 (48 hr PD), Day 4 (72 hr PD), Day 5 (96 hr PD), Day 6 (120 hr PD), Day 7 (144 hr PD), and Day 10 (216 hr PD), and Day 13 (288 hr PD)
|
predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours (hr) postdose (PD) on Day 1; thereafter on Day 2 (24 hr PD), Day 3 (48 hr PD), Day 4 (72 hr PD), Day 5 (96 hr PD), Day 6 (120 hr PD), Day 7 (144 hr PD), and Day 10 (216 hr PD), and Day 13 (288 hr PD)
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Mean terminal elimination phase half-life (t1/2) for E2730 and the N-acetyl metabolite (M1) in plasma
Tidsramme: predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours (hr) postdose (PD) on Day 1; thereafter on Day 2 (24 hr PD), Day 3 (48 hr PD), Day 4 (72 hr PD), Day 5 (96 hr PD), Day 6 (120 hr PD), Day 7 (144 hr PD), and Day 10 (216 hr PD), and Day 13 (288 hr PD)
|
predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours (hr) postdose (PD) on Day 1; thereafter on Day 2 (24 hr PD), Day 3 (48 hr PD), Day 4 (72 hr PD), Day 5 (96 hr PD), Day 6 (120 hr PD), Day 7 (144 hr PD), and Day 10 (216 hr PD), and Day 13 (288 hr PD)
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Mean apparent total clearance following oral administration (CL/F) of E2730
Tidsramme: predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours (hr) postdose (PD) on Day 1; thereafter on Day 2 (24 hr PD), Day 3 (48 hr PD), Day 4 (72 hr PD), Day 5 (96 hr PD), Day 6 (120 hr PD), Day 7 (144 hr PD), and Day 10 (216 hr PD), and Day 13 (288 hr PD)
|
predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours (hr) postdose (PD) on Day 1; thereafter on Day 2 (24 hr PD), Day 3 (48 hr PD), Day 4 (72 hr PD), Day 5 (96 hr PD), Day 6 (120 hr PD), Day 7 (144 hr PD), and Day 10 (216 hr PD), and Day 13 (288 hr PD)
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Mean apparent volume of distribution at terminal phase (Vz/F) for E2730 in plasma
Tidsramme: predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours (hr) postdose (PD) on Day 1; thereafter on Day 2 (24 hr PD), Day 3 (48 hr PD), Day 4 (72 hr PD), Day 5 (96 hr PD), Day 6 (120 hr PD), Day 7 (144 hr PD), Day 10 (216 hr PD), and Day 13 (288 hr PD)
|
predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours (hr) postdose (PD) on Day 1; thereafter on Day 2 (24 hr PD), Day 3 (48 hr PD), Day 4 (72 hr PD), Day 5 (96 hr PD), Day 6 (120 hr PD), Day 7 (144 hr PD), Day 10 (216 hr PD), and Day 13 (288 hr PD)
|
|
Mean metabolite ratio (%) (MRP) in plasma
Tidsramme: predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours (hr) postdose (PD) on Day 1; thereafter on Day 2 (24 hr PD), Day 3 (48 hr PD), Day 4 (72 hr PD), Day 5 (96 hr PD), Day 6 (120 hr PD), Day 7 (144 hr PD), and Day 10 (216 hr PD), and Day 13 (288 hr PD)
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Metabolite ratio (%) is calculated as the ratio of plasma AUC(0-inf) of a metabolite to a parent following molar correction.
|
predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours (hr) postdose (PD) on Day 1; thereafter on Day 2 (24 hr PD), Day 3 (48 hr PD), Day 4 (72 hr PD), Day 5 (96 hr PD), Day 6 (120 hr PD), Day 7 (144 hr PD), and Day 10 (216 hr PD), and Day 13 (288 hr PD)
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Mean amount of unchanged drug excreted (Ae) in urine for E2730 and the N-acetyl metabolite (M1)
Tidsramme: Days 1 through Days 7 at the following intervals: predose; 0 to 4, >4 to 8, >8 to 12, >12 to 24, >24 to 48, >48 to 72, >72 to 96, >96 to 120, and >120 to 144 hours postdose
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Days 1 through Days 7 at the following intervals: predose; 0 to 4, >4 to 8, >8 to 12, >12 to 24, >24 to 48, >48 to 72, >72 to 96, >96 to 120, and >120 to 144 hours postdose
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|
Renal clearance (CLR) of E2730 and the N-acetyl metabolite (M1)
Tidsramme: Days 1 through Days 7 at the following intervals: predose; 0 to 4, >4 to 8, >8 to 12, >12 to 24, >24 to 48, >48 to 72, >72 to 96, >96 to 120, and >120 to 144 hours postdose
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Days 1 through Days 7 at the following intervals: predose; 0 to 4, >4 to 8, >8 to 12, >12 to 24, >24 to 48, >48 to 72, >72 to 96, >96 to 120, and >120 to 144 hours postdose
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Percent (%) of administered dose of E2730 and the N-acetyl metabolite (M1) excreted in urine
Tidsramme: Days 1 through Days 7 at the following intervals: predose; 0 to 4, >4 to 8, >8 to 12, >12 to 24, >24 to 48, >48 to 72, >72 to 96, >96 to 120, and >120 to 144 hours postdose
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Days 1 through Days 7 at the following intervals: predose; 0 to 4, >4 to 8, >8 to 12, >12 to 24, >24 to 48, >48 to 72, >72 to 96, >96 to 120, and >120 to 144 hours postdose
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Mean metabolite ratio (%) (MRP) for E2730 and the N-acetyl metabolite (M1) in urine
Tidsramme: Days 1 through Days 7 at the following intervals: predose; 0 to 4, >4 to 8, >8 to 12, >12 to 24, >24 to 48, >48 to 72, >72 to 96, >96 to 120, and >120 to 144 hours postdose
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Days 1 through Days 7 at the following intervals: predose; 0 to 4, >4 to 8, >8 to 12, >12 to 24, >24 to 48, >48 to 72, >72 to 96, >96 to 120, and >120 to 144 hours postdose
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
9. februar 2018
Primær færdiggørelse (Faktiske)
26. september 2018
Studieafslutning (Faktiske)
26. september 2018
Datoer for studieregistrering
Først indsendt
26. februar 2018
Først indsendt, der opfyldte QC-kriterier
26. februar 2018
Først opslået (Faktiske)
2. marts 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. marts 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. marts 2019
Sidst verificeret
1. februar 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- E2730-A001-002
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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